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The purpose of this study is to assess the safety and effectiveness of 2 doses of ustekinumab compared with placebo (inactive medication) in adult Japanese participants with severe atopic dermatitis.
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (one of the study medications is inactive), multicenter, parallel group study (each participant group receives different treatments simultaneously). Participants will be randomly assigned in a 1:1:1 ratio to receive either ustekinumab 45 mg, ustekinumab 90 mg, or placebo. The study will consist of a screening period, a 12-week double-blind treatment period, and a 12-week follow-up period. During the double-blind treatment period, participants will receive one subcutaneous injection of study medication at Week 0 and Week 4. Participants will return to the study center for 7 evaluation visits on Weeks 2, 4, 8, 12, 16, 20, and 24. Clinical response will be evaluated by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), photography, and Dermatology Life Quality Index (DLQI). Participants will record their itch condition twice daily using the participant daily diary from 2 weeks prior to randomization until Week 12. Blood samples will be drawn at time periods during the screening, double-blind treatment, and follow-up periods. Participant safety will be monitored throughout the study. Participants are permitted to use concomitant topical medications, as defined in the protocol and without any increase in dose, from 4 weeks prior to randomization through to the end of the treatment period. After Week 12, additional treatment can be started or the dose of concomitant medications can be increased, if no improvement in clinical response is observed; in these cases EASI, IGA, and photography evaluations will be stopped. The study duration for each participant is expected to be approximately 30 weeks. Ustekinumab (also known as STELARA) is an antibody medication that inhibits the inflammatory proteins IL-12 and IL-23 and is approved as a treatment for moderate to severe plaque-type psoriasis; this study will examine whether ustekinumab can provide benefit in atopic dermatitis and assess for any risks or side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ustekinumab 45 mg | Experimental |
| |
| Ustekinumab 90 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab | Drug | Participants will receive subcutaneous (SC) injections of either ustekinumab 45 mg or ustekinumab 90 mg at Week 0 and Week 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90 percent [%]-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Investigator's Global Assessment (IGA) Score of "Clear" or "Almost Clear" at Week 12 | The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease). | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chitose | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4. |
| FG001 | Ustekinumab 45 mg | Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Participants will receive SC injections of placebo at Week 0 and Week 4. |
|
| Concomitant topical medications for atopic dermatitis | Other | Concomitant topical medications (as defined in the protocol) can be used from 4 weeks prior to randomization and throughout the study. However, the dosage cannot be increased and new medications cannot be added until after Week 12. |
|
| Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 |
The atopic dermatitis itch scale (ADIS) will be used to assess pruritus (itching) among participants with AD. It will be evaluated by participant diary kept twice daily,in the morning(morning daily score[MDS]) and evening (Evening Daily Score[EDS]). The start-of-day item set consists of 4 items:itching at time of completing morning diary(Q1),presence of itching during night before(Q2), itching at its worst at night (Q3), and impact of itching on sleep at night(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 23=maximum, with higher scores reflecting greater itching. The end-of day item set also consists of 4 items: itching at time of completing the evening diary(Q1),the presence of itching during the day(Q2),itching at its worst during the day(Q3),and amount of time the participant experienced eczema-related itching(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 24=maximum,with higher scores reflecting greater itching. |
| Baseline and Week 12 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 | The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL. | Baseline and Week 12 |
| Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline | The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. | Week 2, 4, 8, 12, 16, 20 and 24 |
| Number of Participants With an IGA Score of "Clear" or "Almost Clear" | The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease). | Baseline, Week 2, 4, 8, 12, 16, 20 and 24 |
| Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease). | Week 2, 4, 8, 12, 16, 20 and 24 |
| Number of Participants in IGA | The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease). | Baseline, Week 2, 4, 8, 12, 16, 20 and 24 |
| Percent Change From Baseline in EASI Total Score | The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. | Week 2, 4, 8, 12, 16, 20 and 24 |
| Percent Change From Baseline in EASI Sign of Disease Components | The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. | Week 2, 4, 8, 12, 16, 20 and 24 |
| Percent Change From Baseline of Body Region Scores in EASI | The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. | Week 2, 4, 8, 12, 16, 20 and 24 |
| Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 to 3 where 0=none, 1=mild, 2=moderate, 3=severe, on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. | Baseline, Week 2, 4, 8, 12, 16, 20 and 24 |
| Habikino |
| Japan |
| Hamamatsu | Japan |
| Hiroshima | Japan |
| Kumamoto | Japan |
| Kurume | Japan |
| Kyoto | Japan |
| Maebashi | Japan |
| Nagasaki | Japan |
| Osaka | Japan |
| Sapporo | Japan |
| Suita | Japan |
| Tokyo | Japan |
| FG002 | Ustekinumab 90 mg | Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4. |
| BG001 | Ustekinumab 45 mg | Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4. |
| BG002 | Ustekinumab 90 mg | Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90 percent [%]-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. | Full Analysis Set (FAS) included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. Last Observation Carried Forward (LOCF) method was used to impute the missing data. | Posted | Mean | Standard Deviation | percent change | Baseline and Week 12 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Investigator's Global Assessment (IGA) Score of "Clear" or "Almost Clear" at Week 12 | The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease). | FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data. | Posted | Number | participants | Week 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 | The atopic dermatitis itch scale (ADIS) will be used to assess pruritus (itching) among participants with AD. It will be evaluated by participant diary kept twice daily,in the morning(morning daily score[MDS]) and evening (Evening Daily Score[EDS]). The start-of-day item set consists of 4 items:itching at time of completing morning diary(Q1),presence of itching during night before(Q2), itching at its worst at night (Q3), and impact of itching on sleep at night(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 23=maximum, with higher scores reflecting greater itching. The end-of day item set also consists of 4 items: itching at time of completing the evening diary(Q1),the presence of itching during the day(Q2),itching at its worst during the day(Q3),and amount of time the participant experienced eczema-related itching(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 24=maximum,with higher scores reflecting greater itching. | FAS population was used for analysis. LOCF method was used to impute the missing data. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 | The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL. | FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline | The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. | FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively. | Posted | Number | participants | Week 2, 4, 8, 12, 16, 20 and 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an IGA Score of "Clear" or "Almost Clear" | The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease). | FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively. | Posted | Number | participants | Baseline, Week 2, 4, 8, 12, 16, 20 and 24 |
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| Secondary | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease). | FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively. | Posted | Number | participants | Week 2, 4, 8, 12, 16, 20 and 24 |
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| Secondary | Number of Participants in IGA | The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease). | FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively. | Posted | Number | participants | Baseline, Week 2, 4, 8, 12, 16, 20 and 24 |
|
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| Secondary | Percent Change From Baseline in EASI Total Score | The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. | FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively. LOCF method was not applied to impute the missing data. | Posted | Mean | Standard Deviation | percent change | Week 2, 4, 8, 12, 16, 20 and 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in EASI Sign of Disease Components | The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. | FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively. | Posted | Mean | Standard Deviation | percent change | Week 2, 4, 8, 12, 16, 20 and 24 |
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| Secondary | Percent Change From Baseline of Body Region Scores in EASI | The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. | FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively. | Posted | Mean | Standard Deviation | percent change | Week 2, 4, 8, 12, 16, 20 and 24 |
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| Secondary | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 to 3 where 0=none, 1=mild, 2=moderate, 3=severe, on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. | FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively. | Posted | Number | participants | Baseline, Week 2, 4, 8, 12, 16, 20 and 24 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4. | 0 | 27 | 20 | 27 | ||
| EG001 | Ustekinumab 45 mg | Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4. | 0 | 24 | 18 | 24 | ||
| EG002 | Ustekinumab 90 mg | Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4. | 0 | 28 | 16 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Kaposi's varicelliform eruption | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Fatty liver alcoholic | Hepatobiliary disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Erythema ab igne | Skin and subcutaneous tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Skin swelling | Skin and subcutaneous tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Solar dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 17.1. | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Aspartate aminotransferase | Investigations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 17.1. | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 17.1. | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Research | Janssen Research & Development, LLC. | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Ustekinumab 45 mg |
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4. |
| OG002 | Ustekinumab 90 mg | Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4. |
|
|
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4. |
|
|
| OG002 | Ustekinumab 90 mg | Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| OG002 | Ustekinumab 90 mg | Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4. |
|
|
| OG002 |
| Ustekinumab 90 mg |
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4. |
|
|
| OG002 |
| Ustekinumab 90 mg |
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4. |
|
|
| OG002 | Ustekinumab 90 mg | Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4. |
|
|